Actively Recruiting
Medico-economic Evaluation of Immediately Sequential Bilateral Cataract Surgery Compared With Delayed Sequential Cataract Surgery in France
Led by Fondation Ophtalmologique Adolphe de Rothschild · Updated on 2025-12-03
242
Participants Needed
4
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Cataracts are defined as opacification of all or part of the crystalline lens, resulting in reduced vision. It is a common disease in France, affecting more than one in five people over the age of 65, and almost two in three over the age of 85. Cataract treatment is exclusively surgical. In the case of bilateral cataracts, which account for 70% of cases, Delayed Sequential Bilateral Cataract Surgery (DSBCS), which involves operating on both eyes with an interval of a few weeks, is the reference treatment in France. The practice of DSBCS has long been justified by the need to reduce the risk of post-operative complications, essentially refractive error and bilateral endophthalmitis. Today, thanks to numerous technological advances in cataract surgery and new intraoperative standards, these complications have become exceptional. Since 2009, the International Society of Bilateral Cataract Surgeons (ISBCS) has issued a guide to best practice (the ''ISBCS General Principles for Excellence in ISBCS''), enabling surgery on both eyes to be performed on the same day in complete safety. As a result, Immediate Sequential Bilateral Cataract Surgery (ISBCS), which involves operating on both eyes on the same day, could be performed with no additional risk compared to SDBCS, while providing the same level of postoperative visual acuity. In view of these factors, we hypothesize that CCBIS would be an efficient alternative to DSBCS in cases of bilateral cataract, for the patient and his family, the hospital and the health insurance company. In addition, its adoption would reduce delays in access to treatment, thus promoting better access to care in the situation of growing demand for this treatment, particularly in areas with fewer medical facilities. The aim of thisproject is to evaluate the associated costs and quality of life in comparison with CCBSD, based on a prospective, multicenter, randomized controlled trial.
CONDITIONS
Official Title
Medico-economic Evaluation of Immediately Sequential Bilateral Cataract Surgery Compared With Delayed Sequential Cataract Surgery in France
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than or equal to 18 years
- Indication for non-combined cataract surgery under local anaesthesia in both eyes
- Patient scheduled for outpatient cataract surgery
- Availability of a caregiver/accompanying person on the day of surgery and for the 1st day post-surgery
- Resident in France
- Speak and understand French
- Consent to participate in the study
- Affiliated or beneficiary of social security
You will not qualify if you...
- Women of childbearing age
- Surgery scheduled under general anesthesia or combined with other eye surgeries
- Ocular tone greater than 24 mm Hg in at least one eye on day of inclusion
- Presence of risk factors for refractive error such as keratoconus, extreme axial eye length, high myopia with posterior staphyloma, or history of corneal surgery
- Presence of risk factors for endophthalmitis including ocular or periocular infections, immunosuppression, or uncontrolled diabetes
- Presence of risk factors for intraoperative complications such as ocular or anatomical abnormalities, history of retinal detachment, lens dislocation, black cataract, posterior polar cataract, or ocular trauma
- Presence of risk factors for corneal edema (e.g., Fuchs' endothelial dystrophy)
- Presence of vision-related comorbidities such as glaucoma, AMD, amblyopia, or uveitis
- Presence of diabetes with diabetic retinopathy or macular edema
- Patient unable to participate in follow-up including response to questionnaires
- Presence of cognitive disorders that could affect surgery or questionnaire responses
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Chu Morvan
Brest, France
Actively Recruiting
2
Clinical Judge
Marseille, France
Actively Recruiting
3
Cochin Hospital
Paris, France
Not Yet Recruiting
4
Fondation Ophtalmologique Adolphe de Rothschild
Paris, France
Actively Recruiting
Research Team
A
Amelie Yavchitz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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